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There is a group of thirty seven Doctors, Companies. and Researchers that are petitioning the FDA to change the labels on Opiates so that they can no longer be prescribed for MODERATE PAIN and unless you are a cancer patient for SEVERE PAIN the longest you can take Opiates is 90 Days, this group of idiots thinks this is the way to control the drug problem in society, so we thought the stories out of Florida where bad YIKES so far the FDA is not giving these thirty seven and their petition any traction with this idea but we should all beware that there are people out there with definite ideas about no treatment what so ever for those of us in chronic pain and we must be vigilant in guarding our right to pain relief and a quality of life because the time to act is before they snatch it away not after. Its being proactive rather than reactive, "an ounce of prevention beats a pound of cure"

i have no small step for man, but i have 6 tires for mankind,Watch your Toes!

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68 Replies |Report This| Share this:Every Chronic Pain Patient Needs to READ THIS!!!There is a group of thirty seven Doctors, Companies. and Researchers that are petitioning the FDA to change the labels on Opiates so that they can no longer be prescribed for MODERATE PAIN and unless you are a cancer patient for SEVERE PAIN the longest you can take Opiates is 90 Days, this group of idiots thinks this is the way to control the drug problem in society, so we thought the stories out of Florida where bad YIKES so far the FDA is not giving these thirty seven and their petition any traction with this idea but we should all beware that there are people out there with definite ideas about no treatment what so ever for those of us in chronic pain and we must be vigilant in guarding our right to pain relief and a quality of life because the time to act is before they snatch it away not after. Its being proactive rather than reactive, "an ounce of prevention beats a pound of cure"

This scares me, but thank you so much for posting it! I wish that there was some way that all chronic pain patients could come together and demand to be treated decently and fairly and get the medical treatment we deserve-none of us asked for the pain, none of us wanted the pain or the limitations that go with it. I am so tired of being judged and treated like a criminal just because I want relief from the pain so I can still have some quality of life, still be productive, still be there for my family....I wish that all of them could have to deal with what chronic pain patients do for ONE day-maybe we should start our own petition, bury them in signatures, there is a site called change.org where this is possible......I would gladly sign-I am so tired of having to fight for medical treatment for pain I never asked for! And I am tired of being discriminated against just because stupid people abuse medications that chronic pain patients need to take to have some kind of life! Thank you again for this information.

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Report This| Share this:Every Chronic Pain Patient Needs to READ THIS!!!This scares me, but thank you so much for posting it! I wish that there was some way that all chronic pain patients could come together and demand to be treated decently and fairly and get the medical treatment we deserve-none of us asked for the pain, none of us wanted the pain or the limitations that go with it. I am so tired of being judged and treated like a criminal just because I want relief from the pain so I can still have some quality of life, still be productive, still be there for my family....I wish that all of them could have to deal with what chronic pain patients do for ONE day-maybe we should start our own petition, bury them in signatures, there is a site called change.org where this is possible......I would gladly sign-I am so tired of having to fight for medical treatment for pain I never asked for! And I am tired of being discriminated against just because stupid people abuse medications that chronic pain patients need to take to have some kind of life! Thank you again for this information.

I guess the only good news about this article is toward the end it stated that doctors will still uphold to right to prescribe strong Schedule II opioids "off-label" similar to how Neurontin is prescribed "off-label" for nerve pain. So it wouldn't be a mandatory requirement that only cancer patients are treated with strong opioid medication. Still, the article is disturbing.

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Report This| Share this:Every Chronic Pain Patient Needs to READ THIS!!!I guess the only good news about this article is toward the end it stated that doctors will still uphold to right to prescribe strong Schedule II opioids "off-label" similar to how Neurontin is prescribed "off-label" for nerve pain. So it wouldn't be a mandatory requirement that only cancer patients are treated with strong opioid medication. Still, the article is disturbing.

How many millions of doctors, companies, and researchers are out there, that I should waste my time worrying what 37 think?

Of course there are people out there who disagree with me and how I feel about these medicines. Everyone should be aware of that and do what they can do to protect themselves. But I am not going to worry needlessly about this group.

Of course there are people out there who disagree with me and how I feel about these medicines. Everyone should be aware of that and do what they can do to protect themselves. But I am not going to worry needlessly about this group.

Calm down, the article's rules actually do not change anything, except labeling. Doctors are free to continue prescribing these meds as they do now. They can continue to be prescribed off label any way the doctor want to, most drugs can be prescribed any way a doctor wants to once they are approved by the FDA.

It was 35 not 37 participants, on this petition. The article also states that the FDA rarely acts on any of this type of petition.

I went via the link provided and read the entire article. If this is a different article from the one you are talking about, I apologize.

Take care, Annette

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Report This| Share this:Every Chronic Pain Patient Needs to READ THIS!!!Calm down, the article's rules actually do not change anything, except labeling. Doctors are free to continue prescribing these meds as they do now. They can continue to be prescribed off label any way the doctor want to, most drugs can be prescribed any way a doctor wants to once they are approved by the FDA.

It was 35 not 37 participants, on this petition. The article also states that the FDA rarely acts on any of this type of petition.

I went via the link provided and read the entire article. If this is a different article from the one you are talking about, I apologize.

Take care, Annette

Anon_160307 responded:

I would like to bring this discussion back to the forefront. There is an excellent expert dissertation on the website below that counters the claims that this group of 30 or so doctors are making regarding Long Term High Dose Opioid Therapy (LTHDOT) for Chronic Non-Cancer Pain (CNCP). This group of doctors officially belong to the group called "Physicians for Responsible Opioid Prescribing (PROP)": http://updates.pain-topics.org/2012/08/group-petitions-fda-to-change-opioid.html#more

Additionally, there is a FDA transcript via the link below from a 1 1/2 day workshop held in May 2012 (in which PROP was in major attendance) that discusses how to address the need to treat chronic pain while curbing the opioid addiction problem that is believed of course to be an "epidemic":http://www.fda.gov/downloads/Drugs/NewsEvents/UCM309444.pdf

Lastly and most importantly, there is a CHANCE for you to file your comments on the petition DIRECTLY to the FDA. If you would like to submit a comment, you will need to click on the "Comment Now" button directly to the right of the website below to submit your comment: http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-0001

This is finally OUR chance as chronic pain patients to let our voices be heard regarding the changes that PROP is trying to get the FDA to approve (see original post on this thread by TDXSP08 that highlights the changes they are proposing and how those changes will hurt chronic pain patients). If approved, we could fall victim to further restrictions on long term opioid therapy; therapy that increases our quality of life and daily functioning.

Additionally, there is a FDA transcript via the link below from a 1 1/2 day workshop held in May 2012 (in which PROP was in major attendance) that discusses how to address the need to treat chronic pain while curbing the opioid addiction problem that is believed of course to be an "epidemic":http://www.fda.gov/downloads/Drugs/NewsEvents/UCM309444.pdf

Lastly and most importantly, there is a CHANCE for you to file your comments on the petition DIRECTLY to the FDA. If you would like to submit a comment, you will need to click on the "Comment Now" button directly to the right of the website below to submit your comment: http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0818-0001

This is finally OUR chance as chronic pain patients to let our voices be heard regarding the changes that PROP is trying to get the FDA to approve (see original post on this thread by TDXSP08 that highlights the changes they are proposing and how those changes will hurt chronic pain patients). If approved, we could fall victim to further restrictions on long term opioid therapy; therapy that increases our quality of life and daily functioning.

What??? How can they call themselves Dr.s? I thought Dr.s were supposed to help people, not hinder them? How could they even think that way? Wait, i just answered my own question. They do not have chronic pain. Therefore, they feel nothing for those of us with it!

If there is any way i can help fight their ignorance, please let me know? I am very grateful to you, for bringing this to our attention! Thank you, Dennis

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Report This| Share this:Every Chronic Pain Patient Needs to READ THIS!!!What??? How can they call themselves Dr.s? I thought Dr.s were supposed to help people, not hinder them? How could they even think that way? Wait, i just answered my own question. They do not have chronic pain. Therefore, they feel nothing for those of us with it!

If there is any way i can help fight their ignorance, please let me know? I am very grateful to you, for bringing this to our attention! Thank you, Dennis

You can submit a formal comment to the petition filed to the FDA by PROP. I submitted my comment last night. They will be published publicly so if you don't want your first and last name published you can leave those fields blank or just put your first name or first name plus first initial of last name. Your name isn't required on the form.

I recommend using Word or WordPad to type your comment. The comment can only be 2,000 characters so I used the character counting option in Word to keep tabs on the amount of characters my comment contained. I lost all of my words in my comment field after highlighting a couple of sentences to delete them, I hit the backspace button and it deleted everything!! Grrr so mad so I retyped in Word and copied and pasted it into the form.

Once your comment is submitted, they will give you a comment ID number that you can use to view your comment online before publication.

You can submit a formal comment to the petition filed to the FDA by PROP. I submitted my comment last night. They will be published publicly so if you don't want your first and last name published you can leave those fields blank or just put your first name or first name plus first initial of last name. Your name isn't required on the form.

I recommend using Word or WordPad to type your comment. The comment can only be 2,000 characters so I used the character counting option in Word to keep tabs on the amount of characters my comment contained. I lost all of my words in my comment field after highlighting a couple of sentences to delete them, I hit the backspace button and it deleted everything!! Grrr so mad so I retyped in Word and copied and pasted it into the form.

Once your comment is submitted, they will give you a comment ID number that you can use to view your comment online before publication.

I guess the big take away from this is even if it gets passed and the labeling does change to allow a patient only 90 days of opioid medication for only severe pain, doctors still can prescribe the medicine "off-label". But, this group knows that it doesn't take much to curtail many doctors from prescribing opioids to those who need it. They believe this will make doctors think twice before initiating long term opioid therapy, and hence, reduce the amount of opioid prescriptions written, and less prescriptions mean lower diversion and misuse (to them).

The petition is sick because it is basically saying that opioids are not safe for use past 90 days, when there hasn't been any detailed studies done past 12 weeks as the FDA didn't require it. 3 months or 90 days worth of pain is the transition period from acute pain to chronic pain, so with this petition they are trying to shut out many chronic pain patients from access to opioid medications. The label change is targeted at severe acute and/or pallative/end of life pain. So it is important that comments stress that the medications are indeed still effective after 90 days and that stability does occur after the titration period.

There is a faq page (pdf file) you can download on the regulations.gov website. They do read off all of the public comments regarding the issue and they say that is DOES make a difference as they do take the public's greviences into account. I will post my comment as an example (see below):

I am an Engineer but also a wife, a mother, and a chronic pain patient. I suffer from DDD and myofascial pain syndrome. More specifically, the disc at L4-L5 has ruptured and the inner disc material is impacting the L5 nerve root. There is also spinal stenosis, osteoarthritis, bone spurs, and ligamentum flavum at that level. At L5-S1, the disc is completely desiccated and bulging with mass effect on the S1 nerve root. I consider my pain as moderate to severe. I've tried to manage my pain without strong opioids but without them the pain is so tremendous that I am unable to physically walk and sleep becomes an illusion (i.e., life is unbearable) and I cannot care for myself or my family. I have been on strong opioids for 6 years with effective titrations. Many doctors have told me I need a two level spinal fusion. However, I know the success rate for pain relief is only 50-60% and many patients with fusions now have worse pain than they had before surgery, so much worse that they contemplate or commit suicide. I know of someone personally that has committed suicide from the pain caused by fusion surgery. Due to the risks of conventional surgery, I manage my pain conservatively. I have tried most non-narcotic methods for treating my pain and those were the first treatment options offered by my Dr., with COT being the last option. Chiropractic, massage, and acupuncture only provided a few hours of relief and I was going weekly through the help of auto accident insurance. I could never afford to go that frequently now as the cost is mind blowing compared to the cost of office visits, copays for medications, and coinsurance for ESIs. I tried non-narcotic meds alone for 5 years of my chronic pain journey, which is now 12 years and counting. NSAIDS at high doses caused multiple ulcers. Tylenol is toxic to the liver at high doses. Mandates that limit opioid prescriptions for CNCP is not the solution to the prescription drug abuse problem in America.

I guess the big take away from this is even if it gets passed and the labeling does change to allow a patient only 90 days of opioid medication for only severe pain, doctors still can prescribe the medicine "off-label". But, this group knows that it doesn't take much to curtail many doctors from prescribing opioids to those who need it. They believe this will make doctors think twice before initiating long term opioid therapy, and hence, reduce the amount of opioid prescriptions written, and less prescriptions mean lower diversion and misuse (to them).

The petition is sick because it is basically saying that opioids are not safe for use past 90 days, when there hasn't been any detailed studies done past 12 weeks as the FDA didn't require it. 3 months or 90 days worth of pain is the transition period from acute pain to chronic pain, so with this petition they are trying to shut out many chronic pain patients from access to opioid medications. The label change is targeted at severe acute and/or pallative/end of life pain. So it is important that comments stress that the medications are indeed still effective after 90 days and that stability does occur after the titration period.

There is a faq page (pdf file) you can download on the regulations.gov website. They do read off all of the public comments regarding the issue and they say that is DOES make a difference as they do take the public's greviences into account. I will post my comment as an example (see below):

I am an Engineer but also a wife, a mother, and a chronic pain patient. I suffer from DDD and myofascial pain syndrome. More specifically, the disc at L4-L5 has ruptured and the inner disc material is impacting the L5 nerve root. There is also spinal stenosis, osteoarthritis, bone spurs, and ligamentum flavum at that level. At L5-S1, the disc is completely desiccated and bulging with mass effect on the S1 nerve root. I consider my pain as moderate to severe. I've tried to manage my pain without strong opioids but without them the pain is so tremendous that I am unable to physically walk and sleep becomes an illusion (i.e., life is unbearable) and I cannot care for myself or my family. I have been on strong opioids for 6 years with effective titrations. Many doctors have told me I need a two level spinal fusion. However, I know the success rate for pain relief is only 50-60% and many patients with fusions now have worse pain than they had before surgery, so much worse that they contemplate or commit suicide. I know of someone personally that has committed suicide from the pain caused by fusion surgery. Due to the risks of conventional surgery, I manage my pain conservatively. I have tried most non-narcotic methods for treating my pain and those were the first treatment options offered by my Dr., with COT being the last option. Chiropractic, massage, and acupuncture only provided a few hours of relief and I was going weekly through the help of auto accident insurance. I could never afford to go that frequently now as the cost is mind blowing compared to the cost of office visits, copays for medications, and coinsurance for ESIs. I tried non-narcotic meds alone for 5 years of my chronic pain journey, which is now 12 years and counting. NSAIDS at high doses caused multiple ulcers. Tylenol is toxic to the liver at high doses. Mandates that limit opioid prescriptions for CNCP is not the solution to the prescription drug abuse problem in America.

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